Corbus Announces Data on Effects of Resunab (JBT-101) in a Clinical Research Model of Resolution of Inflammation

NORWOOD, MA--(Marketwired - September 28, 2016) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic and serious inflammatory and fibrotic diseases, announced today that Professor Derek Gilroy, Ph.D. presented data on the effects of Resunab in a model of inflammation in healthy volunteers on September 28, 2016. The presentation was made at the 6th European Workshop on Lipid Mediators at Goethe University in Frankfurt am Main, Germany.

Dr. Gilroy, Professor of Experimental Inflammation and Pharmacology at University College of London, presented preliminary data testing effects of Resunab (JBT-101) in a clinical research model of inflammation and its resolution in healthy volunteers. In this established model, inflammation is triggered in healthy individuals by the subcutaneous injection of heat-killed E. coli. Blood flow to the site of inflammation is measured with laser Doppler techniques. Suction blisters are generated over the site of inflammation, and cells and inflammatory mediators are measured in the blister fluid at different times after the injection of E. coli. Subjects receive either oral Resunab or placebo prior to the procedure.

The first set of data is from 15 subjects (5 on placebo, 5 on 5 mg Resunab twice a day and 5 on 20 mg Resunab twice a day). The top dose of Resunab in this study is the same as the top dose in the Phase 2 clinical trials currently underway with Resunab in cystic fibrosis, systemic sclerosis and dermatomyositis, respectively.

Professor Gilroy's group found that both doses of Resunab exerted potent anti-inflammatory effects by inhibiting neutrophil infiltration, a key determinant of inflammation severity, by approximately 70%. Resunab correspondingly decreased micro-vascular blood flow around the site of inflammation at 4 hours post stimulus. These two phenomena are related to a decrease in the inflammatory activation phase of this model. The investigators also found that Resunab progressively increased micro-vascular flow around the site of inflammation during the early phases of resolution (10-24 hours post stimulus), an event believed to drive an efficient acute inflammatory response and signal its timely resolution. These results are consistent with previous findings from experiments that tested Resunab's effects in animal models of inflammation and support Resunab's potential to deliver therapeutic benefit in chronic inflammatory diseases as a first-in-class "pro-resolution" drug. Click here to access a summary of the preliminary data from this study.

"These are very exciting data. While conventional immune modulatory agents dampened the signs and symptoms of inflammation, none are curative while most have undesirable side effects; the latter may arise from interfering with the body's own healing process of resolution. With Resunab, we have a drug which is both anti-inflammatory and pro-resolution. We are particularly excited by these findings and to understand the internal signaling systems used by Resunab that exhibits such a favorable result in humans," stated Professor Gilroy.

Barbara White, M.D., Chief Medical Officer of the Company, commented, "The results from this study support the intended pharmacological activity of Resunab, which is resolution of chronically activated innate immune responses, including tissue inflammation and fibrosis. We look forward to continued collaborations with Dr. Gilroy and his colleagues, to further define the impact of Resunab on inflammatory responses -- especially resolution -- in humans."

Corbus is currently developing its novel synthetic oral endocannabinoid-mimetic drug, Resunab, that is designed to resolve chronic inflammation and halt fibrosis. Resunab is currently being evaluated in three separate Phase 2 clinical studies in diffuse cutaneous systemic sclerosis ("systemic sclerosis"), cystic fibrosis ("CF"), diffuse cutaneous, and skin-predominant dermatomyositis. Corbus expects to report top-line data from its Phase 2 clinical study in systemic sclerosis in the fourth quarter of 2016. Corbus recently announced that it has completed subject enrollment in its Phase 2 clinical study of Resunab for the treatment of CF and the Company expects to report top-line results from this study early in the first quarter of 2017. The Company expects to complete enrollment and report top line results from the dermatomyositis study in the second half of 2017. A fourth NIH-sponsored clinical study of Resunab in systemic lupus erythematosus ("SLE") is planned to begin during the first half of 2017.

About ResunabResunab is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Preclinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in preclinical models of inflammation and fibrosis. Resunab is designed to trigger the production of "Specialized Pro-resolving Lipid Mediators" that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of multiple inflammatory mediators. Resunab has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without causing immunosuppression.

About CorbusCorbus Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. Our lead product candidate, Resunab, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation, and fibrotic processes. Resunab is currently in Phase 2 clinical studies for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis and skin-predominant dermatomyositis, with a fourth Phase 2 trial in systemic lupus erythematosus planned to commence during the first half of 2017.

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